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A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography


Inclusion Criteria:



- Female

- Any ethnic origin

- No contraindication of routine bilateral mammography

Exclusion Criteria:

- Any contraindications to mammographic screening, including but not limited to:

- Significant existing breast trauma

- Pregnancy

- Lactating

- Previous surgical biopsy

- Previous breast cancer

- Placement of an internal breast marker

- Breast implants

- Unable to understand and execute written informed consent

- Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single
exposure

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To detect a statistically significant increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. The ROC curves will be generated from the probability of malignancy scale, a score of 0% to 100%.

Outcome Time Frame:

Fall 2010

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

09-03

NCT ID:

NCT00971087

Start Date:

September 2009

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • breast cancer screening
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Fletcher Allen Health CareBurlington, Vermont  05401
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of VirginiaCharlottesville, Virginia  22908
Elizabeth Wende Breast ClinicRochester, New York  14620
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Spectrum HealthGrand Rapids, Michigan  49503
Boca Raton Community HospitalBoca Raton, Florida  33486
University of CincinnatiCincinnati, Ohio  45267-0502
University Hospitals Case Medical CenterCleveland, Ohio  44106
UC DavisSacramento, California  95817
HOAG Memorial HospitalNewport Beach, California  92658-6100
Magee Women's HospitalPittsburgh, Pennsylvania  15213
Scottsdale Medical Imaging Ltd. (SMIL)Scottsdale, Arizona  85251
Invision/Sally JobeGreenwood Village, Colorado  80111
Memorial FloridaHollywood, Florida  33021
Luthern General - Advocate Health CareChicago, Illinois  60068
Barnes JewishSt. Louis, Missouri  63110
York - Women's Imaging at Apple HillYork, Pennsylvania  17403
UTSW Center for Breast CareDallas, Texas  75039
Memorial Hermann/ Memorial CityHouston, Texas  77074
Intermountain Medical ImagingMurray, Utah  84175